Support Regulatory Affairs

Vor 5 Tagen

Bern, Schweiz We make it GmbH Vollzeit

We make it GmbH is a nationally active company in Switzerland with a high level of expertise in the field of personnel services thanks to many years of successful experience.

Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT.
We at it GmbH set the highest standards for quality, ethics and discretion.

For our client, a renowned pharmaceutical company based in Bern, we are looking for a Support Regulatory Affairs (f/m/d)

Background

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. In Bern more than 1800 employees develop and deliver life-saving therapies to treat people with rare and serious medical conditions worldwide.

Tasks
- Support GRA Region Intercontinental team members to obtain and maintain registration of products within ICO Region in collaboration with the local regulatory teams within the Region (Latin-America, Middle east, Africa, CIS, Russia, Turkey and eastern Europe (non-EU)
- Monitor local regulatory activities to ensure business objectives and timely implementation.
- Be responsible for a specific submission package (new product/indication submission, variations, renewal) from preparation to submission in the region, by coordinating the preparation of the modules with the appropriate stakeholders.
- Interact with Global Labelling relating to the labeling activities in the Region.
- Support for the overall coordination and dispatch of responses to Health Authority questions, which include:

- Preparing answers for simple questions not requiring product expertise or input from other internal stakeholders.
- Supporting internal stakeholders for the strategy, planning and preparation of response for complex scientific questions requiring product expertise.

**Requirements**:

- A degree in Biological or Medical Science or Pharmacy or equivalent
- At least 3 years professional experience in Regulatory Affairs within international markets.
- Good communication skills Fluent in English and any other language as Spanish, French, Arabic, Russian is an advantage.

Work hours
- 41\. h./ Week

Are you interested?

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